Approval · Notice of Compliance 18345 · 2016
KEYTRUDA: Notice of Compliance 18345
Issued August 9, 2016
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 18345
- Date
- August 9, 2016
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Alternate drug substance manufacturing and test site; additional drug product manufacturing facility; new dosage form
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | 02456869 | Marketed |
Medicinal ingredients
- PEMBROLIZUMAB 25 MG per ML